The Drug Naming Process
Drugs often have several names. A marketed drug may have up to four different types of names: a chemical name, a company name, a generic name, and a brand name.
Chemical name: When a drug is first discovered, it is given a chemical name. This describes the atomic or molecular structure of the drug. The chemical name is thus usually too complex and cumbersome for general use and is almost never used to identify the drug in a clinical or marketing setting.
Company name: A shorthand version of the chemical name, referred to as a code name (such as RU 486) is developed for easy reference among researchers. A company that is developing a new drug will use a company code to identify it within the company. The company code name for a drug is used prior to designation of a generic name.
Generic & Brand names: When a drug is approved by the FDA, it is given a Generic (official) name and a Brand (proprietary or trademark or trade) name. For example, Dilantin is a drug that is used to prevent seizures. Dilantin is the brand name for this drug and phenytoin is the generic name. Both names are describing the exact same drug. The generic name is assigned, in the United States, by an official body—the United States Adopted Names (USAN) Council. The brand name is developed by the company requesting approval for the drug, and identifies it as the exclusive property of that company.
Factors to consider when naming pharmaceutical drugs
Several regulatory agencies such as the US FDA and the UK's Medicines and Healthcare Products
Regulatory Agency (MHRA) provide guidelines for pharmaceutical companies to follow when developing new product names:
Product names should not contain attributes easily confused with scientific names
Product names should not mislead consumers with respect to the following areas: —Therapeutic effects of the product —Composition of the product —Safety of the product
Product names should be distinct from other product names
Product names may engender mixed reactions in some cases. Companies can invest resources in creating brand names that appeal to an international audience. Typically, pharmaceutical companies engage multiple parties—including marketing managers, naming agencies, corporate-identity firms, advertising firms, customers, and distributors. This is in an effort to safeguard themselves against product naming failures during the name selection process.
A successful product name includes the following attributes:
- Relevance to product category - Connotations - Overall liking - Ease of recognition and recall - Distinctiveness - Consistency with the company and its existing product line
When developing a generic product name, Council research indicates that companies may select a name that connects to the drug’s existing substances and actions. Additionally, pharmaceutical companies often design product names based on brand association with an intended connotation, as described in the Table below.
There are also challenges in properly naming a product:
Multiple uses - a drug maintains more than one pharmacological purpose, making it difficult to identify one name that represents the drug’s many uses.
New property identification - scientists discover a new property that alters the drug’s intended use, thereby preventing experts from accurately naming the drug in a timely manner.
Premature-naming - product naming occurs before the company understands the drug’s therapeutic use, causing scientists to spend additional time renaming the drug.
Pharmaceutical naming begins by identifying white space, or possible opportunities, based on the competitive environment, trends within a therapeutic class, and trademark activity. This sort of research produces baseline data on messages already in the marketplace and which companies “own” those messages and also to help identify potential opportunities for the asset’s brand. From here, it is smart to build out an overall naming strategy that includes a variety of potential word associations and naming paths, ranging from descriptive to creative. If budget and time are available, eliciting direction from the target audience can help identify naming stimuli, unmet needs, etc., relating to the asset.
With word associations and naming paths identified, brand name development begins. This process includes several rounds of brainstorming and list creation to arrive at the strongest options for the asset’s brand. Customarily, a brand development team will explore a variety of ideal functional and aspirational brand attributes, benefits, imagery, and associations to create potential name candidates. In conjunction with the client team, the brand development team establishes guidelines for which word parts and concepts to explore and which ones to avoid.
Once names are created, the next step is to screen them against the developed naming strategy. At this point, since the names haven’t been thoroughly vetted yet, screening entails more cursory searches rather than in-depth research, which happens later in the process. Then, initial legal searches are conducted on the names that make it into further testing. At this point in the process, comprehensive testing and research should be conducted.
The information and insights from this research provide the content to help pharmaceutical companies build submission whitepapers to support the safety and viability of the asset’s proposed proprietary name. An outline of research that should be conducted can be found below. This robust research process isn’t necessary for every pharmaceutical company, but it is the best and most standard practice for consideration. It is common that asset’s branding team become comfortable with three to five names in order to have a back-up in the event of unforeseen regulatory challenges during the final name review and approval process.
Trademark Availability Screens
Trademark availability screening is necessary for any name that is considered for use. Screening occurs via databases and must be checked in any geographical region that is relevant. Trademark availability screening is crucial in order to prevent any existing trademark conflict.
Linguistics evaluations test names in all of the markets in which the drug may be sold. This includes evaluating the language spoken in those markets as well as any cultural or religious aspects that may affect the naming process (ex. different meanings and connotations or translation issues)
Phonetic Orthographic Computer Analysis (POCA)
This analysis checks any phonetic or orthrographic overlap between drugs that were once marketed or are currently marketed. This is a strictly US practice.
Medication Error Prevention and Analysis (Look-alike/Sound-alike Testing)
Look-alike testing evaluates existing electronic or handwritten scripts. This identifies differences based on handwriting and lettering format.
Sound-alike testing evaluates pronunciation of currently marketed drugs.
this article was earlier published on http://www.pharmexec.com
Source: Addison Whitney Health